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Clinical Study to Test the Effects of a Low-Carbohydrate Diet on Body Weight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351845
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : April 22, 2009
Information provided by:
Provident Clinical Research

Brief Summary:
The purpose of this study is to test the effects of a modified carbohydrate diet versus a portion controlled diet in overweight or obese men and women on body weight.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Low carbohydrate diet (behavior) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate the Effect of a Modified Carbohydrate Diet on Body Weight in Overweight or Obese Men and Women
Study Start Date : April 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Primary Outcome Measures :
  1. Differences between and within modified carbohydrate and portion-controlled (control) diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body weight. [ Time Frame: week 12 and week 36 ]

Secondary Outcome Measures :
  1. Differences between and within modified carbohydrate and control diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body fat mass (FM). [ Time Frame: wwek 12 and week 36 ]
  2. Differences between and within modified carbohydrate and control diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in trunk fat. [ Time Frame: week 12 and week 36 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and women 18 to 65 years of age.
  • Waist circumference measurement at Visit 1 (week -1) of ³ 87 cm for females and ³ 90 cm for males.
  • Subject agrees to discontinue all use of supplements or multivitamins (except for those provided during study period) by Visit 2 (week 0).
  • Normally active and judged to be in good health on the basis of medical history and routine laboratory tests.
  • Subject must be willing to follow the assigned diet and maintain usual physical activity level throughout the trial.
  • Subject understands the procedures and requirements of the study by providing written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

  • Weight loss of > 10 lb in the two months prior to screening.
  • Body mass index (BMI) > 37.0 kg/m2.
  • Current smoker (any cigarette use) or history of smoking within 6 months prior to screening.
  • Postmenopausal women who are current users of hormone therapy or have discontinued hormone therapy within 2 months prior to screening.
  • History or presence of significant cardiac, renal, hepatic, pulmonary, biliary, or endocrine disorders.
  • Uncontrolled hypertension (systolic blood pressure ³ 160 mm Hg or diastolic blood pressure ³ 100 mm Hg on two consecutive visits).
  • History of recurrent nephrolithiasis, or an acute episode of nephrolithiasis within the last year prior to screening.
  • History of symptomatic cholelithiasis, unless subject has undergone cholecystectomy.
  • History of gastrointestinal surgery for weight-reducing purposes.
  • Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes (controlled lactose intolerance or gastroesophageal reflux disease are acceptable.)
  • Pancreatic disease: pancreatic enzyme deficiency, history of pancreatitis.
  • Fasting blood glucose ≥ 126 mg/dL at visit 1 or diagnosed diabetes mellitus.
  • Use of any weight loss medications, supplements, programs, or meal replacement products intended to alter body weight within 4 weeks of the screening visit or during the course of the study. Occasional use of meal replacement bars or shakes as snacks is acceptable.
  • History or presence of cancer in the past 2 years, except for successfully resected basal cell carcinoma of the skin.
  • Psychiatric disorders requiring medications (i.e., selective serotonin reuptake inhibitors) or which could interfere with the subject's compliance to the requirements of the protocol.
  • History or current presence of any diagnosed eating disorders (binge eating, bulimia, history of anorexia).
  • Use of systemic corticosteroids, androgens, or phenytoin.
  • Use of pseudo-ephedrine during the study period.
  • Use of lipid-lowering drugs or supplements, unless dose stable prior to enrollment (2 months prior for drugs, 2 weeks prior for supplements).
  • Use of drugs for regulating hemostasis, other than stable dose aspirin.
  • Use of thyroid hormones, except stable-dose replacement therapy for ≥ 2 months prior to enrollment.
  • Abnormal laboratory test results of clinical significance, including, but not limited to total cholesterol > 300 mg/dL or triglycerides > 400 mg/dL.
  • Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, post-tubal ligation, or ³ 1 year postmenopausal.
  • Recent history of (within past 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as > 14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1 ½ oz distilled spirits).
  • Participation in another clinical study within 30 days prior to screening visit (week -1).
  • Individual has a condition the Investigator believes would interfere with the evaluation of the subject or put the subject at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351845

Sponsors and Collaborators
Provident Clinical Research
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Principal Investigator: Kevin C Maki, PhD Radiant Research Chicago

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Responsible Party: Kevin C. Maki, PhD, Provident Clinical Research Identifier: NCT00351845     History of Changes
Other Study ID Numbers: 203470
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms